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Efficacy and safety of the dipeptidyl peptidase-4 inhibitor gemigliptin compared with sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone.
MedLine Citation:
PMID:  23320436     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
AIMS: This study was designed to assess the efficacy and safety of a DPP-4 inhibitor, gemigliptin, versus sitagliptin added to metformin in patients with type 2 diabetes. METHODS: We conducted a double-blind, randomized, active-controlled trial in 425 Asian patients with inadequately controlled type 2 diabetes being treated with metformin alone. Eligible patients were randomized into 3 groups: 50 mg gemigliptin qd, 25 mg gemigliptin bid or sitagliptin 100 mg qd added to ongoing metformin treatment for 24 weeks. HbA1c and fasting plasma glucose (FPG) were measured periodically, and oral glucose tolerance tests were performed at baseline and 24 weeks after starting the treatment regimen. RESULTS: Twenty-four weeks later, adding gemigliptin (50 mg/day) to ongoing metformin therapy significantly improved glycemic control. Reduction in HbA1c caused by 50 mg gemigliptin qd (-0.77%±0.8) was non-inferior to that caused by 100 mg sitagliptin qd (-0.8%±0.85). Proportion of patients achieving HbA1c <7% while taking 25 mg gemigliptin bid (50%) or 50 mg gemigliptin qd (54.07%) was comparable to the results with 100 mg sitagliptin qd (48.87%). There were significant decreases in FPG, postprandial glucose and AUC(0) (-2h) glucose, as well as increases in GLP-1 and beta cell sensitivity to glucose (supported by HOMA-β, postprandial 2-h c-peptide and insulinogenic index) in patients receiving gemigliptin treatment with their metformin therapy. There was no increased risk of adverse effects with this dose of gemigliptin compared to sitagliptin 100 mg qd. CONCLUSIONS: Addition of gemigliptin 50 mg daily to metformin was shown to be efficacious, well tolerated and non-inferior to sitagliptin in patients with type 2 diabetes mellitus.
Authors:
E Rhee; W Lee; K Min; V K Shivane; A R Sosale; H Jang; C Chung; I Nam-Goong; J Kim; S Kim;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-16
Journal Detail:
Title:  Diabetes, obesity & metabolism     Volume:  -     ISSN:  1463-1326     ISO Abbreviation:  Diabetes Obes Metab     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-16     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100883645     Medline TA:  Diabetes Obes Metab     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2013 Blackwell Publishing Ltd.
Affiliation:
Department of Endocrinology and Metabolism (E.J.R., W.Y.L., S.W.K.), Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul.
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